NCT00002349

Brief Summary

To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection. Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Jan 1995

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

4.3 years

First QC Date

November 2, 1999

Last Update Submit

April 13, 2011

Conditions

HIV Infections

Keywords

AIDS-Related ComplexStavudine

Interventions

StavudineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Recent HIV infection.
  • No prior antiretroviral therapy.
  • No acute opportunistic infection at study entry.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Intractable diarrhea.
  • Bilateral peripheral neuropathy.
  • Any other condition that would preclude study therapy.
  • Concurrent Medication:
  • Excluded:
  • Myelosuppressive, neurotoxic, or hepatotoxic drugs.
  • Patients with the following prior condition are excluded:
  • History of bilateral peripheral neuropathy.
  • Prior Medication:
  • Excluded:
  • Prior antiretroviral therapy.
  • Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

San Diego Naval Hosp

San Diego, California, 921345000, United States

Location

Naval Med Ctr

Portsmouth, Virginia, 237085100, United States

Location

Northwest Med Ctr

Seattle, Washington, 98122, United States

Location

Related Publications (1)

  • Katlama C, Molina JM, Rozenbaum W, Valantin MA, Modai J, Chauveau E, Ngo Van P, Gres JJ. Stavudine ( D4T ) in HIV infected patients with CD4 less than 350/mm3: results of a double-blind randomized placebo controlled study. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:89

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAIDS-Related Complex

Interventions

Stavudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

January 1, 1995

Primary Completion

May 1, 1999

Study Completion

May 1, 1999

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations

US(3)